Single-incision surgery for female stress urinary incontinence, supported by high-quality evidence Juran Review

Female stress urinary incontinence refers to the involuntary discharge of urine when there is increased abdominal pressure such as coughing, and it affects 10% to 40% of middle-aged women
.

Retropubic and transobturator midurethral suspension (MUS) are the current treatments, but these two procedures have a high complication rate
.

In order to solve this problem, the single-incision sling midurethral sling (SIMS) came into being.
It has a single vaginal incision and avoids puncture, hematoma, organ damage, etc.
, but the first SIMS product is unstable due to anchoring.
Delisting due to low success rate and other reasons
.

Subsequent improved SIMS products have been introduced, but data comparing the efficacy and safety of SIMS and MUS are still limited so far
.

 On March 31, 2022, the New England Journal of Medicine (NEJM) published a randomized trial comparing SIMS and MUS in 21 hospitals in the UK
.

The results showed that SIMS was non-inferior to MUS in terms of subjective success rate at 15 months, and the success rates remained similar between the two groups at 36 months
.

 "NEJM Medical Frontiers" specially invited Professor Zhu Lan, chairman-designate of the Obstetrics and Gynecology Branch of the Chinese Medical Association, and Professor of Obstetrics and Gynecology of Peking Union Medical College Hospital to interpret this research
.

To read the full text translation, please visit the official website of NEJM Medical Frontiers, APP or click on the WeChat applet picture
.

Zhu Lan*, Ye Yang, Department of Obstetrics and Gynecology, Peking Union Medical College Hospital; National Clinical Research Center for Obstetrics and Gynecology *Corresponding author Stress urinary incontinence is a common urinary The most common gynecological urological disorder with involuntary leakage from the urethra
.

In 1990, Petros and Ulmsten proposed the "hammock" hypothesis of stress urinary incontinence to explain the pathogenesis of stress urinary incontinence: the anatomical structure of the pubourethral ligament exists near the middle urethra, which acts as a fulcrum in the presence of increased abdominal pressure.
The rotation of the surrounding urethra makes the middle urethra "knotted", and the failure of the middle urethra to form a good "hammock" makes it impossible to incontinence when the abdominal pressure increases
.

 Based on this theory, Ulmsten creatively proposed mid-urethral slings (MUS) as a surgical procedure for stress urinary incontinence
.

By stabilizing and strengthening the "hammock" structure of the retropubic urethra in the middle of the urethra, this procedure acts as a "pseudopubourethral ligament" and supports the urethra when the abdominal pressure increases, thereby effectively treating stress urine incontinence
.

A Cochrane systematic review showed that the long-term subjective success rate after midurethral sling over 5 years could be maintained at 43%-92% [1]
.

The operation has a landmark significance in the field of gynecology and urology
.

 Mid-urethral suspension can be divided into two surgical approaches: retropubic and transobturator
.

Transpubic midurethral suspension is to pass the synthetic sling on both sides and under the middle urethra through the retropubic area to form a U-shaped structure to support and strengthen the middle urethra; transobturator midurethral suspension is to The central part of the synthetic sling is placed under the middle of the urethra to support it, and both ends of the sling are fixed to the obturator
.

The long-term safety and efficacy of these two MUS procedures have been tested by many clinical trials, and they have been considered as long-term effective, safe and widely used standard anti-urinary incontinence procedures
.

 In 2006, a new single-incision sling midurethral sling (single-incision mini-slings, SIMS) was introduced to the market
.

In this procedure, a synthetic sling is placed in the middle of the urethra through an incision in the anterior vaginal wall and tightly anchored to the middle of the urethra to support the urethra
.

Because the SIMS procedure has the advantages of shorter placement of sling material, avoidance of retropubic or transobturator puncture, etc.
, shorter operative time, less intraoperative bleeding, easier sling removal when the sling is exposed, and reduced retropubic area bladder Risk of injury and pain in the groin area
.

 The first SIMS product, TVT-SECUR, was found to be significantly inferior to MUS in long-term patient success in multiple clinical trials due to the limitations of the sling material being not tightly attached to the middle urethra and unstable anchoring
.

The product was withdrawn from the market in 2012, causing setbacks for the application of SIMS products
.

 Subsequently, other improved SIMS products were launched one after another, and small-scale studies were carried out
.

A systematic review published in European Urology in 2014 suggested that SIMS products other than TVT-SECUR had similar subjective and objective success rates compared with MUS products at an average follow-up of 18 months, but these studies had small sample sizes, The heterogeneity is large, and there is a large risk of bias [3]
.

The 2017 Cochrane systematic review believes that the existing research evidence is not enough to judge the efficacy of non-TVT-SECUR SIMS and MUS, and there is a lack of strictly controlled and long-term follow-up SIMS randomized clinical trials
.

 The single incision sling study [4] published in the New England Journal of Medicine (NEJM) is an open-label, non-inferiority, randomized controlled trial of SIMS in the treatment of female stress urinary incontinence.
At the 36-month follow-up period, SIMS was defined as "non-inferiority" when the postoperative success rate was less than or equal to 10% lower than that of MUS on the premise that SIMS was better than MUS in the perioperative period
.

 The primary outcome measure selected for the single-incision sling study was the patient's subjective success rate of the Patient Global Impression of Improvement (PGI-I) questionnaire at 15 months of postoperative follow-up, with "very significant improvement" and "significant improvement" as the success criteria
.

Secondary outcome measures were pain level within 14 days after surgery, perioperative recovery, objective success rate at 15 months after surgery, and a validated patient urinary incontinence symptom questionnaire (International Advisory Committee on Urinary Incontinence Questionnaire ICIQ-UI/FLUTS).
, Quality of Life Questionnaire (European Five-Dimensional Health Scale EQ-5D-3L) and Sexual Life Quality Questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire PISQ-IR)
.

 In addition, the authors counted all adverse events from the perioperative period to 36 months of postoperative follow-up
.

The results of the study suggest that the subjective success rate of incontinent patients who received SIMS at 15 months postoperatively was non-inferior to those who received MUS, and the success rates of the two procedures remained similar at 36 months postoperatively
.

A total of 600 patients were included in the study, of which 298 patients in each of the SIMS and MUS groups were eventually randomized, and 257 patients in each group underwent planned surgery
.

 The overall follow-up rate for the primary outcome of the trial was 87.
4% at 15 months postoperatively and 81.
4% at 36 months
.

The primary outcome of the 15-month follow-up subjective success rate was 79.
1% in the SIMS group and 75.
6% in the MUS group (adjusted risk difference, 4.
6%; 95% CI, -2.
7% to 11.
8%; P<0.
001 for noninferiority).
); at 36 months of follow-up, the powers of the two groups were 72.
0% and 66.
8%, respectively (adjusted risk difference, 5.
7%; 95% CI, -1.
3% to 12.
8%)
.

In terms of objective success rates, the 15-month follow-up success rates in the two groups were 85.
7% and 75.
5%, respectively (adjusted risk difference, 5.
2%; 95% CI, -5.
9%-16.
2%)
.

These results suggest that Adjust and Altis (the two main slings included in this study) single-incision sling midurethral suspension is non-inferior to standard retropubic and transobturator midurethral suspensions in terms of subjective success rates at 15-month follow-up.
Hanging
.

 In terms of perioperative conditions, the SIMS group had more people using local anesthesia, more people with intraoperative blood loss less than 50 ml, shorter postoperative hospital stay, and lower pain score within 14 days after operation.
The pressure test adjusted the sling in more numbers than the standard midurethral sling
.

In terms of adverse events, the number of intraoperative bladder injuries in the perioperative SIMS group was less than that in the control group, while the number of vaginal mucosal injuries at the surgical site was more than that in the control group
.

In terms of complications during long-term follow-up, the SIMS group had significantly more pain in the groin or thigh than the control group, and the difference was only statistically significant at the 15-month follow-up period.
There were statistically significant differences at follow-up 15 months and 36 months after surgery
.

In addition, although there was no statistical significance between the two groups in terms of the total number of patients undergoing follow-up procedures, more patients with SIMS underwent additional procedures due to sling-related adverse events such as sling exposure, pain, or recurrent incontinence
.

 In conclusion, this study, in a tightly controlled, long-term follow-up randomized controlled trial, suggests that SIMS with adjustable anchoring is non-inferior to standard midurethral sling in terms of subjective patient success rates at 15 months of follow-up, and both.
Group subjective success rates remained similar at 36 months of follow-up
.

The limitations of this study are: (1) Only 36-month follow-up data were reported, and data on long-term surgical success rates and adverse events for 10 years or more were lacking
.

The efficacy and safety of the standard MUS procedure have been demonstrated by a number of studies with 10 years or more of follow-up
.

However, the results of our team's 10-year long-term follow-up study of unadjustable SIMS showed that the long-term success rate of the surgery decreased faster than that of standard MUS surgery.
It is very important in the effect of the SIMS technique and the standard MUS technique
.

 (2) This study is an unblinded trial and may introduce some bias
.

 (3) Although this study failed to obtain too many data with statistically significant differences in long-term postoperative adverse events between the two groups, this may be due to the good long-term postoperative safety and adverse events in the two groups.
are caused by less, and may also be caused by insufficient follow-up time
.

 SIMS is a third-generation midurethral suspension developed after the retropubic and transobturator approaches, with the advantages of less trauma and fewer perioperative complications
.

However, the current research on the long-term treatment effect of SIMS mainly focuses on the non-adjustable sling SIMS (TVT-SECUR), and a number of clinical trials and observational studies suggest that the long-term effect of this procedure is inferior to MUS
.

A 10-year prospective cohort study by our team also suggested that the subjective and objective cure rates of non-adjustable SIMS were inferior to transobturator MUS
.

We look forward to the long-term follow-up results of SIMS versus standard MUS to clarify the optimal surgical management of stress urinary incontinence
.

Reference 1.
Ford AA, Rogerson L, Cody JD, et al.
Mid-urethral sling operations for stress urinary incontinence in women.
Cochrane Database Syst Rev 2017;7:CD006375.
2.
Sun Z, Wang X, Lang J, et al.
al.
Comparison of outcomes between single-incision sling and transobturator sling for treating stress urinary incontinence: A 10-year prospective study.
Neurourology and urodynamics 2019;38:1852-8.
3.
Mostafa A, Lim CP, Hopper L, et al.
Single -incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications.
European urology 2014;65:402-27.
4.
Abdel‑Fattah M, Cooper D, Davidson T, et al.
Single-incision mini-slings for stress urinary incontinence in women.
N Engl J Med 2022;386:1230-43.
The author introduces Professor Zhu Lan, Director of the Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Chief Physician, Doctoral Supervisor, winner of the 2020 He Liang He Li Award, Director-designate of the Obstetrics and Gynecology Branch of the Chinese Medical Association, and Obstetrics and Gynecology of the Chinese Medical Doctor Association Member of the Standing Committee and Director General of the Chinese Medical Association, Chairman of the Special Committee on Pelvic Floor Disease Prevention and Control of the Chinese Preventive Medicine Association, Chairman of the Obstetrics and Gynecology Professional Committee of the Chinese Academy of Physician Training, Head of the Gynecology Pelvic Floor Research Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association, International Member of the Academic Naming Committee of the Gynecological and Urological Association, Chairman of the Sino-French Pelvic Floor Rehabilitation Alliance
.

Research areas include gynecological urology, female pelvic floor reconstruction surgery, minimally invasive gynecological surgery and female reproductive tract deformities
.

A series of new surgical procedures have been developed, including concordant full pelvic floor reconstruction
.

Ye Yang is a doctoral candidate at the Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
.

Main research direction: female stress urinary incontinence, female reproductive tract malformation, as the first author, published a total of 4 papers in Chinese Journal of Obstetrics and Gynecology, Sci CHINA Life Sci, Reprod Sci, Biomed Res Int and other journals, many times in China Conference speech
.

Copyright information This article is translated, written or requested by the editorial department of "NEJM Frontiers of Medicine"
.

For translations and articles written from English products of NEJM Group, please refer to the original English version
.

The full text of the Chinese translation and the included diagrams, etc.
, are exclusively authorized by the Massachusetts Medical Association NEJM Group
.

For reprinting, please contact nejmqianyan@nejmqianyan.
cn
.

Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal responsibility
.